NCT02926924

Prophylactic Application of an Incisional Wound Vac to Prevent Wound Complications in Obese Spine Surgery Patients

Completed NA Results posted Last updated 11 April 2025

What this trial tests

NA trial testing Wound Vac in Spine Surgery in 68 participants. Completed in 15 January 2015.

Timeline

1 August 2011

Primary endpoint
15 January 2015

15 January 2015

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	68
Start date	1 August 2011
Primary completion	15 January 2015
Estimated completion	15 January 2015
Sites	1 location across United States

Drugs / interventions tested

• Wound Vac
• Standard Dressing — full drug profile →

Conditions studied

• Spine Surgery — all drugs for Spine Surgery →
• Wounds Vac — all drugs for Wounds Vac →

Sponsor

University of Michigan

Who can join

18 and older, any sex, with Spine Surgery or Wounds Vac. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Count of Patients With Post Operative Infection Primary · 6 weeks post surgery

Count of Patients with Post operative infection requiring return to operating room or prolonged treatment of antibiotics

readmission

Group	Value	95% CI
Standard Dressing	4
Wound Vac	2

prolonged antibiotic use

Group	Value	95% CI
Standard Dressing	5
Wound Vac	3

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks after surgery. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard Dressing

Serious: 4/19 (21%)

Deaths: 0/19

Wound Vac

Serious: 2/22 (9%)

Deaths: 0/22

Serious adverse events (1 terms)

Reaction	System	Standard Dressing	Wound Vac
Readmission to Hospital	Surgical and medical procedures	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Standard Dressing	Wound Vac
prolonged antibiotic use required	Infections and infestations	—	—

Most-reported serious reactions: Readmission to Hospital.

Data from ClinicalTrials.gov NCT02926924 adverse events section.

Sponsor's own description

This is a prospective randomized study evaluating the use of a prophylactic incision wound vac dressing, applied in the OR, on patients undergoing posterior spine surgery with a BMI\>35. Patients are randomized in the operating room to normal postoperative dressing vs. vac dressing. The vac dressing would be left on for 72 hours postoperatively. In the interim, the patients' postoperative care can proceed as usual. Our primary outcomes will be antibiotics or return trip needed to the operating room for wound related complications.

The patients only intervention would be the application of an incisional wound vac. The will be no change in the patients postoperative protocol otherwise. This procedure is noninvasive.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Negative pressure wound therapy for surgical wounds healing by primary closure.
   Webster J, Liu Z, Norman G, Dumville JC, et al · · 2019 · cited 73× · PMID 30912582 · DOI 10.1002/14651858.cd009261.pub4
2. Negative pressure wound therapy for surgical wounds healing by primary closure.
   Norman G, Shi C, Goh EL, Murphy EM, et al · · 2022 · cited 71× · PMID 35471497 · DOI 10.1002/14651858.cd009261.pub7
3. Negative pressure wound therapy for surgical wounds healing by primary closure.
   Norman G, Goh EL, Dumville JC, Shi C, et al · · 2020 · cited 48× · PMID 32542647 · DOI 10.1002/14651858.cd009261.pub6
4. Negative pressure wound therapy for surgical wounds healing by primary closure.
   Norman G, Goh EL, Dumville JC, Shi C, et al · · 2020 · cited 38× · PMID 32356396 · DOI 10.1002/14651858.cd009261.pub5
5. Negative Pressure Wound Therapy in Spinal Surgery.
   White AJ, Gilad R, Motivala S, Fiani B, et al · · 2022 · cited 9× · PMID 36354525 · DOI 10.3390/bioengineering9110614